DelfaGLP-1 Atlas

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CompletedPhase 1

A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects

Lead sponsor

Sanofi

Asset

SAR425899

Subcutaneous · GLP-1 / glucagon dual

Listed sites

2

Recruiting sites

—

Enrollment

24

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 28-40•HbA1c ≤6.5%

Primary endpoint

•Sleep energy expenditure

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03376802
Org study IDPDY15012
Secondary IDU1111-1191-5658UTN

Timeline

Milestones

Study first posted2017-12-19actual
Study start2018-04-18actual
Primary completion2018-12-27actual
Study completion2018-12-27actual
Last update posted2022-04-25actual

Assets

Investigational agents

SAR425899

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Overweight to obese male and female subjects.
•Body mass index 28 - 40 kg/m2.
•18 to 50 years of age
•Fasting plasma glucose ≤125 mg/dL.
•Glycated hemoglobine (HbA1c) ≤6.5%.
•Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia).
•No concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker).
•Females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive.

Exclusion criteria

•Elevated liver enzymes, lipase, amylase, or calcitonin at screening.
•Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening.
•Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
7
Safety / tolerability / PK
5
Glycemic / diabetes
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Fat mass and fat-free mass

Time frame:Baseline to Day 20

Total fat mass

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Fasting plasma glucose

Time frame:20 days

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c

Time frame:Baseline to Day 20

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)

Time frame:20 days

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Adverse events

Time frame:Up to 27 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 16

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 16

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 16

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 16

Half-life

descriptive

Other (unclassified)

7 endpoints
Primary/protocol endpoint/low confidence

Sleep energy expenditure

Time frame:Baseline to Day 19

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Total daily energy expenditure

Time frame:Baseline to Day 19

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Resting energy expenditure

Time frame:Baseline to Day 19

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Basal energy expenditure

Time frame:Baseline to Day 19

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Respiratory quotient (RQ)

Time frame:Baseline to Day 19

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Diet Induced Thermogenesis (DIT)

Time frame:Baseline to Day 19

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Ketone bodies

Time frame:20 days

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.